MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT

Lot Number 0030807929

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Event Description

It was reported that the device was contaminated.A 4.00 x 20mm synergy xd drug-eluting stent was selected for use.After implanting the device, a yellow substance was noted inside the packaging of the bag.The device remains inside the patient.There were no patient injuries reported.

Manufacturer Narrative

Device evaluated by mfr: received for analysis was the dual chamber pouch (dcp) / inner pouch, from this synergy xd mr ous 4.00 x 20mm.An examination of the pouch noted that the pouch had been opened however, an examination of the inside of the inner pouch identified a yellow residue stretching across the pouch.The yellow residue was scanned and it was found to be a condensate from molten polymer vapors collected from exhaust ductwork over a film extruder, at the site of the external vendor manufacturing site.The amber colored oily substance (yellow substance trapped in the pouch) is consistent with the appearance of condensate, which the vendor manufacturer had identified in the past.The dual chamber pouch is composed of 7 layers.The residue is encapsulated between the foil and nylon layer - a puncture resistant layer, preventing a barrier to movement of the residue towards the seal layer and the product chamber.Therefore, the residue did not come in contact with the inner facing layer of the pouch which would be in contact with the actual device.

Event Description

It was reported that the device was contaminated.A 4.00 x 20mm synergy xd drug-eluting stent was selected for use.After implanting the device, a yellow substance was noted inside the packaging.The device remains inside the patient.There were no patient injuries reported.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18107765
• MDR Text Key: 329200151
• Report Number: 2124215-2023-61220
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0030807929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1